Welchol as Monotherapy for Type 2 Diabetes Mellitus

January 24, 2014 updated by: Daiichi Sankyo, Inc.

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Efficacy and Safety of Welchol as Monotherapy for Type 2 Diabetes Mellitus

The current study investigates Welchol as monotherapy to improve glycemic control in subjects with Type 2 Diabetes Mellitus not adequately controlled with diet and exercise alone. The study will evaluate if Welchol monotherapy for Type 2 Diabetes Mellitus will be safe, well tolerated and efficacious.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

357

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
      • Birmingham, Alabama, United States, 35216
      • Montgomery, Alabama, United States, 36117
      • Muscle Shoals, Alabama, United States, 35662
    • Arizona
      • Green Valley, Arizona, United States, 85614
      • Mesa, Arizona, United States, 85203
      • Mesa, Arizona, United States, 85210
      • Tucson, Arizona, United States, 85741
      • Tucson, Arizona, United States, 85723
      • Tucson, Arizona, United States, 85705
    • Arkansas
      • Searcy, Arkansas, United States, 72143
    • California
      • Buena Park, California, United States, 90620
      • Burbank, California, United States, 91505
      • Chula Vista, California, United States, 91910
      • Garden Grove, California, United States, 92844
      • Huntington Park, California, United States, 90255
      • Irvine, California, United States, 92618
      • La Mirada, California, United States, 90638
      • Lincoln, California, United States, 95648
      • Lomita, California, United States, 90717
      • Los Angeles, California, United States, 90015
      • Los Angeles, California, United States, 90057
      • Los Gatos, California, United States, 95032
      • Santa Ana, California, United States, 92701
      • Tustin, California, United States, 92780
      • Walnut creek, California, United States, 94598
    • Florida
      • Brooksville, Florida, United States, 34601
      • Coral Gables, Florida, United States, 33134
      • DeLand, Florida, United States, 32720
      • Delray Beach, Florida, United States, 33484
      • Gulf Breeze, Florida, United States, 32561
      • Hialeah, Florida, United States, 33012
      • Jacksonville, Florida, United States, 32223
      • Kissimmee, Florida, United States, 34741
      • Miami, Florida, United States, 33175
      • Miami, Florida, United States, 33169
      • Miami, Florida, United States, 33135
      • New Port Richey, Florida, United States, 34652
      • Ocala, Florida, United States, 34471
      • Ormond Beach, Florida, United States, 32174
      • Pembroke Pines, Florida, United States, 33026
      • Vero Beach, Florida, United States, 32960
      • Wellington, Florida, United States, 33449
      • Winter Park, Florida, United States, 32789
    • Georgia
      • Decatur, Georgia, United States, 30035
      • East Point, Georgia, United States, 30344
      • Roswell, Georgia, United States, 30076
      • Stockbridge, Georgia, United States, 30281
      • Stone Mountain, Georgia, United States, 30083
    • Idaho
      • Nampa, Idaho, United States, 83686
    • Illinois
      • Chicago, Illinois, United States, 60607
    • Indiana
      • Evansville, Indiana, United States, 47714
      • LaPorte, Indiana, United States, 46350
      • South Bend, Indiana, United States, 46614
    • Kentucky
      • Crestview Hills, Kentucky, United States, 41017
    • Louisiana
      • Lafayette, Louisiana, United States, 70503
    • Maryland
      • Prince Frederick, Maryland, United States, 20678
      • Silver Spring, Maryland, United States, 20910
    • Massachusetts
      • New Bedford, Massachusetts, United States, 02740
    • Michigan
      • Southfield, Michigan, United States, 48034
    • Mississippi
      • Port Gibson, Mississippi, United States, 39150
    • Missouri
      • St. Louis, Missouri, United States, 63128
      • St. Louis, Missouri, United States, 63141
    • Montana
      • Billings, Montana, United States, 59101
    • Nevada
      • Las Vegas, Nevada, United States, 89123
    • New Jersey
      • Berlin, New Jersey, United States, 08009
      • Clifton, New Jersey, United States, 07013
      • Mine Hill, New Jersey, United States, 07803
    • New York
      • New Windsor, New York, United States, 12553
      • North Massapequa, New York, United States, 11758-1802
      • West Seneca, New York, United States, 14224
    • North Carolina
      • Lexington, North Carolina, United States, 27295
      • Statesville, North Carolina, United States, 28625
      • Wilmington, North Carolina, United States, 28401
    • Ohio
      • Cincinnati, Ohio, United States, 45219
      • Cincinnati, Ohio, United States, 45227
      • Cincinnati, Ohio, United States, 45245
      • Cleveland, Ohio, United States, 44122
      • Cuyahoga Falls, Ohio, United States, 44223
      • Marion, Ohio, United States, 43302
      • Munroe Falls, Ohio, United States, 44262
      • Shaker Heights, Ohio, United States, 44120
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73103
      • Oklahoma City, Oklahoma, United States, 73159
    • Oregon
      • Portland, Oregon, United States, 97220
    • Pennsylvania
      • Harrisburg, Pennsylvania, United States, 17112
      • Jersey Shore, Pennsylvania, United States, 17740
    • South Carolina
      • Charleston, South Carolina, United States, 29414
      • Charleston, South Carolina, United States, 29412
      • Columbia, South Carolina, United States, 29201
      • Greer, South Carolina, United States, 29651
    • Texas
      • Arlington, Texas, United States, 76012
      • Dallas, Texas, United States, 75230
      • Dallas, Texas, United States, 75235
      • Fort Worth, Texas, United States, 76117
      • Houston, Texas, United States, 77074
      • Houston, Texas, United States, 77008
      • Houston, Texas, United States, 77081
      • Houston, Texas, United States, 77083
      • San Antonio, Texas, United States, 78229
      • Sugar Land, Texas, United States, 77479
      • Tomball, Texas, United States, 77375
    • Utah
      • Salt Lake City, Utah, United States, 84107
      • Salt Lake City, Utah, United States, 84102
    • Virginia
      • Manassas, Virginia, United States, 20110
      • Salem, Virginia, United States, 24153
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53209

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female subjects >= 18 years of age;
  • Women of childbearing potential (WOCBP) must be using an adequate method of contraception as detailed in the protocol.
  • Diagnosis of Type 2 Diabetes Mellitus;
  • HbA1C >= 7.5% and =< 9.5 % at screening;
  • Fasting C-peptide >0.5 ng/mL at screening;
  • Drug naïve (no prior treatment with OAD) or having received no pharmacologic therapy for diabetes for the 3 month period prior to screening;
  • Clinically stable in regards to medical conditions other than type 2 diabetes;
  • Concomitant medications must be at stable doses for at least 30 days prior to enrollment, and are not anticipated to need adjustment during the study period; and
  • Fasting glucose =< 240 mg/dL at randomization

Exclusion Criteria:

  • A history of type 1 diabetes and/or a history of ketoacidosis;
  • History of bowel obstruction;
  • History of hypertriglyceridemia-induced pancreatitis;
  • Fasting serum triglyceride concentrations >500 mg/dL;
  • History of dysphagia, swallowing disorders, gastroparesis, other gastrointestinal (GI) motility disorders, or major GI surgery;
  • History of insulin use of >= 2 weeks duration in the previous 3 months or a total of > 2 months of insulin therapy at any time prior to screening;
  • Two or more fasting self-monitored blood glucose (SMBG) levels >240 mg/dL during the placebo lead-in period.
  • Previous treatment with a bile acid sequestrant, including Welchol within the 3 months prior to screening;
  • Body mass index (BMI) >40 kg/m2;
  • Weight loss > 3% in prior 3 months; and
  • LDL <60 mg/dL.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: placebo
Drug: Placebo
placebo
Experimental: Welchol
Welchol 625mg tablets
Drug: Welchol
Welchol 625mg tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent Change in Hemoglobin A1c
Time Frame: 24 week
change in HbA1c from baseline to Week 24
24 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Fasting Plasma Glucose
Time Frame: from baseline to 24 weeks
to determine changes in Glycemic control after 24 weeks on therapy
from baseline to 24 weeks
% Subjects With a Decrease in HbA1c of >= 0.7 Percentage Units
Time Frame: 24 weeks
to determine the percentage of participants who experience a reduction in HbA1c of at least 0.7 percentage units at 24 weeks from baseline.
24 weeks
% Subjects Achieving an HbA1C Goal of <7.0
Time Frame: 24 weeks
% Subjects achieving an HbA1C goal of <7.0 at 24 weeks
24 weeks
% Subjects With a Decrease in FPG >=30 mg/dL
Time Frame: from baseline to 24 weeks
% Subjects with a decrease in Fasting Plasma Glucose >=30 mg/dL from baseline to 24 weeks
from baseline to 24 weeks
Changes in Total Cholesterol [TC]
Time Frame: from baseline to 24 weeks
To assess the effects of Welchol on changes in total cholesterol [TC]
from baseline to 24 weeks
Changes in Low Density Lipoprotein Cholesterol [LDL-C]
Time Frame: from baseline to 24 weeks
To assess the effects of Welchol on changes in low density lipoprotein cholesterol [LDL-C]
from baseline to 24 weeks
Changes in High Density Lipoprotein Cholesterol [HDL-C]
Time Frame: from baseline to 24 weeks
To assess the effects of Welchol on changes in high density lipoprotein cholesterol [HDL-C]
from baseline to 24 weeks
Changes in Non-HDL-C
Time Frame: from baseline to 24 weeks
To assess the effects of Welchol on changes in non-HDL-C
from baseline to 24 weeks
Changes in Triglycerides [TG]
Time Frame: from baseline to 24 weeks
To assess the effects of Welchol on changes in triglycerides [TG]
from baseline to 24 weeks
Changes in Apolipoprotein A-I (apoA-I)
Time Frame: from baseline to 24 weeks
To assess the effects of Welchol on changes in apolipoprotein A-I (apoA-I)
from baseline to 24 weeks
Changes in Apolipoprotein B (apoB)
Time Frame: from baseline to 24 weeks
To assess the effects of Welchol on changes in apolipoprotein B (apoB)
from baseline to 24 weeks
Change in Postprandial Plasma Glucose, 2 Hours After a Meal Tolerance Test
Time Frame: from baseline to 24 weeks
To assess the change from baseline on postprandial plasma glucose, 2 hours after a meal tolerance test
from baseline to 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Daiichi Sankyo, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

November 10, 2008

First Submitted That Met QC Criteria

November 10, 2008

First Posted (Estimate)

November 13, 2008

Study Record Updates

Last Update Posted (Estimate)

February 27, 2014

Last Update Submitted That Met QC Criteria

January 24, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WEL-305

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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